Update to FDA Guidance for Food Allergen Labeling

On January 6, 2025, FDA published the food allergen labeling-related final guidance document, Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5). The questions and answers in the final guidance inform the legal requirements of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).  

What does this mean for those with tree nut allergy?

The FDA has reduced its list of tree nuts requiring food allergen labeling to 12 types of tree nut (previously 23 types).

These are the tree nuts that continue to require food allergen labeling: 

• Almond
• Black walnut
• Brazil nut
• California walnut
• Cashew
• Filbert (also known as hazelnut)
• Heartnut (also known as Japanese walnut)
• Macadamia nut (also known as Bush nut)
• Pecan
• Pine nut (also known as pinon nut)
• Pistachio
• English and Persian walnut

The FDA now excludes the following tree nut species from the list of "tree nuts” that must follow food allergen labeling requirements: 

• Coconut
• Cola (kola) nut
• Beech nut
• Butternut
• Chestnut
• Chinquapin
• Ginkgo nut
• Hickory nut
• Palm nut
• Pili nut
• Shea or shea nut

Using the example of coconut, coconut will no longer be recognized as a tree nut requiring food allergen labeling under the law. You will no longer see coconut listed in a “Contains: tree nuts (coconut)” statement on food labels. But you will continue to see coconut listed individually in the ingredient list when used in a food.

What does this mean for those with egg allergy?

The FDA has expanded its definition of “egg” for food allergen labeling purposes. The FDA now considers eggs from domesticated chickens, ducks, geese, quail, and other birds to be “eggs” for the purpose of food allergen labeling.

Using the example of duck egg, a product that contains a duck egg will be labeled as “duck egg” in the ingredient list and in the “Contains” statement (if a “Contains” statement is used).

Note that FALCPA requires, and continues to require, that ingredients derived from egg such as albumin be listed and treated as a major food allergen and also be required to identify the type of fowl or poultry source, e.g., albumin (duck egg).

What does this mean for those with milk allergy?

The FDA has expanded its definition of milk for food allergen labeling purposes. The FDA now considers milk from other domesticated ruminant animals (not just cows) including goats, sheep, or other ruminants to be “milk” for the purpose of food allergen labeling.

Using the example of goat milk, a product that contains goat milk will be labeled as “goat milk” in the ingredient list and “Contains” statement (if a “Contains” statement is used).

Note that FALCPA requires, and continues to require, that ingredients derived from milk such as whey be listed and treated as a major food allergen and also be required to identify the type of ruminant or animal source, e.g., whey (goat milk).

What is the timeline for these changes to affect consumers?

Labeling changes can appear on food product labeling now for tree nuts, eggs, and milk.

For tree nuts, specifically coconut, changes to eliminate a “Contains: tree nuts (coconut)” label statement may not be required until January 1, 2028 (note: pending confirmation from FDA). Since food products containing coconut ingredients often have a fairly long shelf life, we expect removal of the “Contains: tree nuts (coconut)” statement to happen over time, rather than immediately or in the shorter term. 

As always, FARE recommends carefully reading ingredient lists every time a food is purchased and consumed.

For coconut and the other tree nut species removed requiring food allergen labeling, the FDA has not indicated that they are no longer recognized food allergens, only that FALCPA labeling requirements no longer apply. Food manufacturers have an additional option of using a “Additional food allergen [X allergen]” or “Other food allergen [X allergen]” statement either immediately following a “Contains” statement, if used, or immediately following the ingredient list (if a “Contains” statement is not used). FARE encourages food manufacturers to use this option to continue to educate our community about the presence of coconut as a food allergen in foods.

Food labels can change without notice, so it is good practice to check them consistently, even for products that you use regularly. By reading labels multiple times—at purchase, during storage, and before usage—you can ensure that the product still aligns with your needs and avoid any unexpected ingredients.

How can I be sure that a food label is truthful when it says it is “Free from” a major allergen?

FARE believes that “Free-from” labeling claims on foods must be clearly scientifically justified. FDA provided more clarity in its final Q&A to food manufacturers about appropriate use of voluntary “Free from” food allergen claims in food labeling. It states that voluntary “free-from [X food allergen]” claims cannot be used in food labeling when the package also lists a voluntary precautionary allergen labeling (PAL) statement such as “May contain [X food allergen]” or “Manufactured in a facility that also processes [X food allergen].” This will provide greater clarity, trust, and assurance to our food allergy community with “Free from” claims.